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Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen (APAPSubQ)

S

Saint-Joseph University

Status and phase

Completed
Phase 2

Conditions

Fever
Drug Reaction
Drug Effect
Pain

Treatments

Drug: Acetaminophen

Study type

Interventional

Funder types

Other

Identifiers

NCT03635684
APAPSC2018

Details and patient eligibility

About

Subcutaneous perfusion is an underused technique, the effectiveness of which has been demonstrated.

A number of drugs of different therapeutic classes, including morphine, have a good level of scientific evidence for use by this route.

Subcutaneous Acetaminophen injection is being used in some medical centers, mainly in Europe, despite the lack of definite evidence on its efficacy.

This study aims to quantify the degree of effectiveness of subcutaneous Acetaminophen infusions for pain or fever in Geriatrics and Palliative Care, as well as determining its safety.

Full description

Subcutaneous perfusion is an underused technique, the effectiveness of which has been demonstrated. It is mainly used in Palliative Care and Geriatrics when a venous line is not available. It is a simple and comfortable technique that allows to administer solutes and / or medications continuously or discontinuously in the subcutaneous tissue.

A number of drugs of different therapeutic classes, including morphine, have a good level of scientific evidence for use by this route.

Subcutaneous Acetaminophen injection is being used in some medical centers, mainly in Europe, despite the lack of definite evidence on its efficacy. It is sometimes accused of causing pain at the injection site; it seems that this is not the case if it is infused slowly, over 20 minutes to 30 minutes. There is no report of serious local effects.

The consultation palliative care team at Hôtel-Dieu de France (HDF) has used subcutaneous Acetaminophen infusions repeatedly without adverse effects since January 2014.

This study aims to quantify the degree of effectiveness of subcutaneous Acetaminophen infusions for pain or fever in Geriatrics and Palliative Care, as well as determining its safety.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Patients seen by the Palliative Care Consultation Team, patients admitted in the Palliative Care Unit, or Geriatric patients (patients aged 65 and older) in participating centers in Lebanon
  • Presence of pain or fever necessitating the administration of Paracetamol
  • Absence of an Intravenous Line

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

SC Acetaminophen
Experimental group
Description:
Palliative Care or Geriatric Patients who receive subcutaneous Acetaminophen for pain or fever relief
Treatment:
Drug: Acetaminophen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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